ECHA is looking for comments on nine proposals to identify new substances of very high concern. Give comments by 17 October 2022.
Helsinki, 7 September 2022 – The substances and examples of their uses are:
4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). Used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
Melamine (EC 203-615-4, CAS 108-78-1). Used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). Used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants.
The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.
Safety Data Sheets (SDS) are documents for communicating information on the hazards of chemicals and mixtures and the risks they pose to human health and the environment.
The European Commission amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDS):
COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
31st December 2022 – after this date, all safety data sheets will need to be updated to the new requirements.
The new requirements include:
Alignment of SDS with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revisions 7 and 8;
Inclusion of Unique Formula Identifiers (UFIs) to Section 1 (in line with Regulation (EU) 2017/542);
Additional information requirements for substances placed on the market as a nanoform (in line with Regulation (EU) 2018/1881) and for substances and mixtures with endocrine-disrupting properties;
Addition of the Specific Concentration Limits (SCLs), multiplying factors and acute toxicity estimates (ATE), if available, set in accordance with CLP 1272/2008.
The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12.
Chromium trioxide (EC No. 215-607-8; CAS No. 1333-82-0) is widely used in plating and surface treatment.
Notifications from 1 026 sites across Europe submitted by May 2021. confirm that chromium trioxide is still widely used in functional or hard chrome plating and surface treatment. The annual usage is estimated to be 7 000 tonnes. The substance of very high concern was placed on the Authorisation List in 2013 and its use has needed a specific authorisation in the EU since 2017.
By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.
In December 2020 European Commission published 2 decisions granting authorisation to use the chemical until September 2024.
Enforcement authorities can now carry out inspections as necessary.
There are 2 principal duties for companies using chromium trioxide:
Apply for REACH authorisation in time;
Comply with the conditions comunicated by suppliers through extended safety data sheets.
The chromium trioxide applications for REACH authorisation by companies is now accelerating.
Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024.
Ekotox Centers offer complex services to prepare all necessary documents on behalf of the customers. To stay on the market there is need for immediate action!
On the same time there is a duty to comply with the safety measures and operational conditions – requirements defined for downstream users by eSDS. To be sure that all is in compliance Ekotox Centers provide support to manage „Internal Dossiers for REACH Authorisation Compliance“ (IDRAC).
Skin sensitising substances in consumer mixtures: Current call for comments and evidence
The France, Ireland and Germany request interested parties to submit information on skin sensitising substances in mixtures intended for consumers, including data on types of uses, planned substitutions, epidemiological data on allergic contact dermatitis and information on healthcare costs.
Deadline for providing input: 30/09/2022.
The objective of this Call for Evidence is to gather information on:
the sectors, and type of uses/applications concerned,
measures currently in place (e.g. changed formulation, reduction of concentration, specific packaging, conditions of use) to minimise consumer exposure,
experience regarding substitution efforts, availability and costs of alternatives or reasons for non-substitution,
the potency of the skin sensitising substances and their technical functions in the mixtures,
on safe use of consumer products,
epidemiology of allergic contact dermatitis and other health-related information including health costs,
analytical methods to detect the presence of skin sensitising substances in mixtures.
For any clarifications, please contact the German Competent Authority: chemg (at) baua.bund.de
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
A new definition of a nanomaterial
POP’s Persistent Organic Pollutants
Summary of the RAC and SEAC committees
Enforcement Forum Inspection Reports
Further reviews of the active substances in biocidal products
Group assessment of chemicals
Another substance on the candidate list
New developments concerning the authorisation of biocidal products
Confirmed projections of an increase in sales of heated tobacco products in EU countries
A new definition of a nanomaterial
The EC proposed new definition of nanomaterials, which will replace the one from 2011. Nanomaterial is subject to regulatory control, it has the power to regulate chemicals (REACH) as well as regulations regarding their use in certain applications, such as biocides, cosmetics or food.
The Commission adopts an agreement to protect human health and the environment against persistent organic pollutants (POPs). The agreement paves the way for the establishment of strict limits for these chemicals in waste. Existing limits have been tightened for five substances and new limits have been agreed for four new substances
The Committee adopted opinions on the harmonized classification and labelling of glyphosate and silver and the restriction of lead content in shooting and fishing ammunition. Opinion supporting the restriction of 2,4-dinitrotoluene (2,4-DNT) in articles has been completed. The Committee also adopted an opinion on the reduction of Dechlorane Plus. The consultation on the draft opinions started in June and you can submit your comments on the ECHA website.
The inspectors carried out checks on the REACH authorization requirements for substances from Annex XIV of REACH. Another project examined whether substances recovered from waste should be registered under REACH or whether they could benefit from an exemption. EU-wide inspections of biocidal products containing approved or not yet approved active substances are also ongoing until the end of the year. Reports on the results of the inspection will be published at the end of 2022.
Further reviews of the active substances in biocidal products
The ECHA Committee adopted a record number of opinions at its June meeting. They concern nine opinions on EU authorization, five on applications for active substances, including: active chlorine, calcium compounds, peracetic acid, lactic acid and IPBC. The Committee does not support the EU authorization for hydrogen peroxide in group 2. Please note that biocidal products containing approved active substances are subject to product registration under the new European procedures.
ECHA published the 4th substance evaluation report in 2021. In 2021, evaluations of over 1,900 substances were finalized, most of them grouped on the basis of their structural similarity. About 25% of the substances assessed require further risk management. Companies need to proactively update their REACH registrations with up-to-date information on substances. The ECHA report also highlights the sharp increase in the number of substances requiring harmonized classification and labeling (CLH).
N- (hydroxymethyl) acrylamide was added to the Candidate List as it may cause cancer or genetic defects. These substances may be included in the authorization list in the future. If a substance is on this list, its use will be prohibited unless companies apply for authorization and the European Commission allows them to continue using it.
New developments concerning the authorisation of biocidal products
The biocidal product SOPUROXID contains peroxyacetic acid as an active substance which is included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012. Authorised by the European Union with effect from 12 July 2022 to 30 June 2032 for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT3 (Veterinary hygiene) and PT4 (Food and feed area) in the form of a soluble concentrate for indoor industrial and professional use, method of application – hand treatment (mopping).
Confirmed projections of an increase in sales of heated tobacco products in EU countries
The European Commission has published an analysis of sales and use of heated tobacco products among consumers under 25, confirming an increase in sales at retail level of more than 10% between 2018 and 2020 in more than five Member States from data in the EU-CEG database.
We encourage you to read the current news of EkotoxInfo chemical news.
In the summary of last month you will find the following topics:
Update of the safety data sheets by the end of 2022
Mapping of potentially harmful chemicals
Summary of the March meeting of the Biocidal Products Committee
Summary of the RAC and SEAC meeting
New CoRAP substance evaluation list for 2022-2024
Revision of the REACH and CLP regulations
Updating the registration requirements for substances in REACH
Five more substances added to the REACH Authorization List
Updating the list of chemicals subject to export notification
New developments concerning the approval of biocidal products
Update of safety data sheets by the end of 2022.
We remind you that in June 2020. Regulation 2020/878 / EU was published, amending Annex II [the content of the safety data sheet] to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The new template for safety data sheets takes into account, inter alia: the need to provide specific concentration limits, as well as multiplication factors and acute toxicity estimates; obligation to provide information on nanoform of particles and the presence of endocrine disruptors.
All existing safety data sheets without changes can be used until December 31, 2022. After this date, only safety data sheets that comply with the latest template as defined in Regulation 2020/878 / EU may be in circulation.
In 2021. ECHA assessed a total of 1900 chemicals and categorized them based on the further regulatory needs for each substance. ECHA’s goal is to review by 2027 all registered chemicals above 1 tonne per year, assign them to the appropriate category and evaluate the further regulatory action of each substance (or group of substances).
On the ECHA website you will find the full list of substances with the assigned category, or information on whether the substance is subject to further regulatory needs, whether the evaluation has already been completed or is under development.
The results of the assessment are a key issue for entrepreneurs as they can affect:
inclusion of a substance in the authorization list
restrictions on the use of certain substances, including ED substances
the need to update REACH registration
Summary of the March meeting of the Biocidal Products Committee
During the meeting, the committee adopted 3 opinions for active substances:
methylene dithiocyanate – no support for use in group 12
(13Z) -hexadec-13-en-11-yn-1-yl acetate – approval in group 9 supported
propiconazole – identified as meeting the exclusion criteria in Group 8
In addition, the committee adopted the following four positive opinions on EU authorizations:
Propan-1-ol – PT1
Propan-2-ol – PT2 and PT4
L – (+) lactic acid – PT2
Active chlorine released from sodium hypochlorite – PT2
Entrepreneurs using the substances listed in the above product groups, after their official approval, will have to apply for registration in European procedures in order to keep the products on the market.
Summary of the RAC and SEAC meeting
In March, a meeting of the Risk Assessment Committees (RAC) and the Socio-Economic Analysis Committee (SEAC) was held. Norway’s proposed restrictions on Dechlorate Plus were supported, arguing that each of the proposed options could be proportional to the benefits to society and the costs incurred. At the meeting, both committees adopted an opinion on the review and evaluation of the industrial use of 1,2-dichloroethane and two opinions on the establishment of occupational exposure limit values (OELs) for 1,4-dioxane and isoprene. In addition, 10 opinions on harmonized classification and labeling were adopted, including the classification of sulfur and multi-wall carbon nanotubes.
New CoRAP substance evaluation list for 2022-2024
The Community rolling plan (CoRAP) has been updated for the period 2022-2024 and is published on the website of the European Chemicals Agency. The plan provides for the evaluation of 27 substances suspected of posing a risk to human health and the environment. Of the 27 substances listed, two were reallocated and 25 substances were moved from the previous list (2021-2023) published on March 17, 2021. Registrants should check whether their dossiers for substances need to be updated with relevant new information, for example on hazard, tonnage, use and exposure, and that the registration dossier does not need to be updated.
Revision of the REACH and CLP regulations
The public consultation on the amendment to the REACH regulation ended on April 15, and the legislative process has moved to the next stage. The impact assessment should be finalized and presented with the Commission proposal in Q4 2022. The revision of the REACH regulation will have a significant impact on producers, workers and users of chemicals across Europe. Some planned changes to the REACH Regulation are expected to increase costs for industry. The CLP Regulation will also be subject to targeted revision, along with other sector-specific chemicals legislation, and the adaptation of the CLP revision is planned for Q2 2022.
Update of substance registration requirements in REACH
On March 24, 2022, the European Commission published amendments to Annexes VI to X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477). The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. In the second half of 2022, ECHA will publish an updated guide to registration requirements. Firms should start preparing to update their substance registration dossiers as the changes will apply in October 2022.
Five more substances added to the REACH Authorization List
ECHA has identified five substances as substances of very high concern (SVHC) due to their reprotoxic, carcinogenic or endocrine disrupting properties. The amendment of the legal act of the list of substances which cover the granting of authorization for use (Annex XIV to REACH) was published on April 11 in the EU Official Journal. Companies wishing to continue using these substances after the sunset date has been indicated will need to submit an application for authorization.
Update of the list of chemicals subject to export notification
The European Commission has updated Annexes I and V to the Prior Informed Consent Regulation (PIC Regulation, (EU) No. 649/2012). The PIC Regulation regulates the import and export of certain hazardous chemicals and places obligations on companies that wish to export these chemicals to non-EU countries. The update was released on April 20, 2022, and will take effect on July 1, 2022.
New developments concerning the approval of biocidal products
Biocide ARIEL chlorine Professional System 5 chlorine bleach for white wash – contains the active substance active chlorine released from sodium hypochlorite, which is included in the list of approved active substances. The authorisation was granted for the period from 24 April 2022 to 31 March 2032.
On the 25 April 2022, the European Commission published a “Restrictions Roadmap” as part of the EU’s Chemicals Strategy. It is in no way legally binding, but rather provides a view into future EU environmental compliance policy. The roadmap provides a list of groups of widely used chemicals of concern that will be targeted for restrictions at the European level in the coming years. This is important because this gives all stakeholders long-term visibility on planned regulatory action and thereby can facilitate existing and future substitution efforts towards safe alternatives.
The plan focuses on entire classes of chemical substances rather than regulating them individually or in small groups as is currently the case. The Restrictions Roadmap will use a group approach to regulating chemicals, in which the most harmful member of a chemical family defines legal restrictions for the whole family. If implemented as intended, thousands of chemical substances will rapidly be restricted in the EU. In total, the European Environmental Bureau (EEB) has estimated the Restrictions Roadmap will lead to the restriction of roughly 5,000 to 7,000, but industry association CEFIC say that up to 12,000 substances could ultimately fall within the scope of the new proposal, which would constitute the world’s “largest ever ban of toxic chemicals”.
European Environmental Bureau ingles out 6 groups of chemicals to be restricted:
Polyvinyl Chloride (PVC) and its additives
PFAS (non-essential uses)
Bisphenols, including BPA
Flame retardants
Chemicals in childcare products that cause cancer, genetic mutation or harm the reproductive system (CMRs)
Toxic chemicals in single use nappies / diapers
The roadmap sets out priorities for the European Chemicals Agency before the revision of the REACH Regulation (estimated for 2027). According to the roadmap, the restriction process will begin within two years by between 2025 – 2027. All substances will be gone by 2030.
COMMISSION STAFF WORKING DOCUMENT Restrictions Roadmap under the Chemicals Strategy for Sustainability:
On March 24 2022, the European Commission published amendments to Annexes VI – X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477).
The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. The changes mainly concern:
determining when further in vivo and in vitro tests on the mutagenic potential of the substance are needed;
identification of the preferred animal species and administration routes in reproductive toxicity studies;
clarification of when long-term studies should be performed instead of short-term aquatic toxicity studies and terrestrial organisms studies;
identify the need for a degradation and bioaccumulation study.
In addition, the registration dossier for substances should include the description of nanoforms, identify crystal structures and UVCB substances, clarify information on impurities and additives, as well as analytical information.
In the second half of 2022, ECHA will publish an updated guide to registration requirements. Companies should start preparing to update their substance registration dossiers as the changes will apply in October 2022.
Main topics: selected news from chemical and related legislation:
Maintaining the authorisation to place biocidal products on the market in Germany
New ECHA recommendations on registration requirements in REACH Regulation
Restriction of PFAS substances
Non-binding guidance for the physical substances sector
Rapid Consultation for S-Metachlor
New cosmetic restrictions for methyl-N-methylanthranilate
New developments concerning the approval of biocidal products
New developments concerning the approval of plant protection products
Notification to undertakings intending to place fluorocarbons on the EU market in large quantities in 2023
EU REACH Reform Web Meetings
* Maintenance of the authorisation to place biocidal products on the market in Germany
The BAuA (Federal Institute for Occupational Safety and Health) in Germany has published new requirements for national authorisations of biocidal products: ‘Neues Meldeverfahren für Biozidprodukte’. Based on the new requirements, biocidal products placed on the German market before 26 August 2021 must be confirmed/re-notified by 31 March 2022 if the product is to remain on the market.
New information and documents are required as part of the new notification. Ignoring the notification obligation means that the product should not be placed on the German market.
New Guideline: https://ekotox.eu/news/biocides-germany-new-rules-on-national-notification/
* New ECHA recommendations on registration requirements in REACH Regulation
ECHA has updated its recommendations on the information to be submitted when registering chemicals to help companies improve the quality of their registration dossiers. The Agency has added further advice on how to apply the read-across approach and on the weight of evidence to be submitted. Specifically, the improvements relate to provisions on how to apply the read-across approach and the weight of evidence and how to combine both approaches, allowing animal testing to be dispensed with.
Registrants should update their REACH registration as necessary to ensure that their dossier meets the information requirements.
The European Chemicals Agency has put forward a proposal for an EU-wide restriction on all per- and polyfluoroalkyl substances (PFAS) in firefighting foams. The proposal is based on information available at the time of its preparation and may be updated in the light of technological progress and new information. The consultation is due to start on 23 March 2022 and will run for a further 6 months.
In addition to the use of PFAS in firefighting foams, five European countries (the Netherlands, Germany, Denmark, Sweden and Norway) are working on a draft restriction that will apply to all PFAS in other applications. They plan to submit their proposal to ECHA in January 2023.
PFAS in firefighting foams : vytvoriť
* Non-binding guidance for the physical substances sector
The preparation of non-binding guidelines for the hairdressing industry is part of a set of commonly agreed measures to support the autonomous implementation of the European Framework Agreement on health and safety at work in the hairdressing industry. In addition to the agreed content, this document provides some information on guidelines on workplace challenges in the context of the COVID-19 pandemic.
Germany notified a draft harmonised classification and labelling (CLH) for S-metolachlor (ISO) and submitted it for consultation, which closed on 3 September 2021, but in the meantime further data on carcinogenicity have emerged.
ECHA has launched a rapid consultation for clarification, which will run until 7 March 2022.
* New cosmetic restrictions for methyl-N-methylanthranilate
On 1 February 2022, the European Commission published Commission Regulation (EU) 2022/135 imposing certain restrictions on the use of methyl-N-methylanthranilate (M-N-MA) in cosmetics. Until now, there were no restrictions on M-N-MA, but the 49th amendment to the IFRA standards limited its use to 0.1% in several product categories due to its phototoxic effects. According to the new entry in Annex III of the EU Cosmetics Regulation, M-N-MA can be used: in leave-on products up to 0.1%; in rinse-off products up to 0.2%. Cosmetics that do not comply with the new restrictions may not be placed on the market after 21 August 2022. In addition, from 21 November 2022, non-compliant products must disappear from shop shelves.
New developments concerning the approval of biocidal products
Biocidal product Mydis – The UK Health and Safety Executive has extended the measure authorising the making available on the Northern Ireland market and use of the biocidal product Mydis until 23 February 2023. (COMMISSION IMPLEMENTING DECISION (EU) 2022/137)
Product containing alkyl (C12-16)benzyldimethylammonium chloride – used as a long-lasting cleaner to remove layers of deposits on wood, brickwork, roofing, paving stone and other surfaces. The product is designed to prevent the growth of unwanted algae and protect against algae. Outdoor application. The product containing the active substance at a concentration of 2,4 % is considered a biocidal product within the meaning of Article 3(1)(a) of Regulation (EU) No 528/2012 and belongs to product type 2. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/146)
Biocidal product Clinisept + Skin Disinfectant – contains as active substance active chlorine released from sodium hypochlorite. Sodium hypochlorite-released active chlorine is approved for use in biocidal products of Type 1 (human personal care) as defined in Annex V to Regulation (EU) No 528/2012. The UK Health and Safety Executive, authorises the making available on the market and use of the biocidal product, until 6 May 2023. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/155)
Biocide product identified in the Register for Biocidal Products by the number BC-RW058475-96 – the label of the biocidal product must include the information: ‘The wearing of chemical resistant protective gloves (glove material to be specified by the authorisation holder in the product information) and disposable protective clothing, at least type 6 of EN 13034 or equivalent protective clothing, is required for handling the product. Where the applicant for authorisation or the authorisation authority identifies measures that achieve a level of exposure reduction equivalent to or greater than that achieved by wearing the protective equipment listed, those measures shall be used in place of the personal protective equipment listed and shall be specified on the biocidal product label and in the authorisation.
Creosol – extension of the measure to restrict the use and placing on the market in France of certain wood treated with creosote and creosote-related substances. The expiry date of the approval of creosote for use in biocidal products of type 8 was 8 September 2021. The approval was extended from the original 27 months to 59 months. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/326)
* New developments concerning the approval of plant protection products
Low-risk active substance Bacillus amyloliquefaciens strain IT-45 – the active substance was approved on 27 February 2022 and the expiry date is 27 February 2037. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/159)
Notification to undertakings intending to place fluorocarbons on the EU market in large quantities in 2023
Fluorocarbons are substances listed in Section 1 of Annex I to Regulation (EU) No …/… HFC-23, HFC-32, HFC-41, HFC-125, HFC-125, HFC-134, HFC-134a, HFC-143, HFC-143a, HFC-152, HFC-152a, HFC-161, HFC-227ea, HFC-236cb, HFC-236ea, HFC-236fa, HFC-245ca, HFC-245fa, HFC-365mfc, HFC-43-10mee.
Any placing on the market of these substances (except where the total annual quantity is less than 100 tonnes of CO2. equivalent per year) is subject to limits under the quota system.
Importers are required to have a valid registration on the F-Gas .portal and the fluorocarbon licensing system at the time of release of the fluorocarbons into free circulation. Such registration shall be considered as a compulsory import licence. A similar licence is required for the export of fluorocarbons.
As of 1 January 2022, importers are required under the European Communities’ Integrated. Tariff (TARIC) to indicate on the Single Customs Document (SAD) the quantities of fluorocarbons in CO2. equivalents at the time of release for free circulation, . and importers should be listed as “consignee”.
Companies must submit a declaration. of estimated quantities for 2023 on the F-Gas portal and in the fluorocarbon. licensing system during the notification period from March 14, 2022 to April 13, 2022, 1 p.m. (CET).
(EUROPEAN COMMISSION, Notice to undertakings. intending to place hydrofluorocarbons in bulk on the market in the European Union in 2023, 2022/C 44/13)
EU REACH Reform Web Meetings
Ecotox Centers invites you to 3 online events to which we have invited representatives of ECHA, Cefic and Eurometalux. The first, April meeting will take place on 26.04.2022r. At the meeting we will discuss the proposed changes to REACH regulation. Participation in the event is free, however the number of places is limited.
Main topics:
new information requirements in the EU REACH registration process;
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